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The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the X Series in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

Semiautomatic Operation (AED): X Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the X Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

ECG Monitoring: The X Series is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients.

External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology; As a standby when standstill or bradycardia might be expected; Suppression of tachycardia; Pediatric pacing.

Non-Invasive Blood Pressure Monitoring: The X Series is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg.

Temperature Monitoring: The X Series is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

SpO2 Monitoring: The X Series pulse CO-oximeter with Masimo Rainbow SET technology is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and/or carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), pleth variability index (PVI), and perfusion index (PI).

Respiration Monitoring: The X Series is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor.

CO2 Monitoring: The X Series is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath rate.

Invasive Pressure Monitoring: The X Series is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

Web Console: X Series Web Console functionality allows medical personnel to view physiological data available on a connected X Series device. Physiological data may include ECG, noninvasive blood pressure, SpO2/SpCO/SpMet, end-tidal carbon dioxide, respiration rate, invasive blood pressure, temperature, and Heart Rate.

The X Series (reviewed and cleared under K133269 and K133484) is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and respiration monitoring). The currently marketed ZOLL X Series device (K133269 and K133484) uses the Masimo Rainbow SET technology to offer the SpO2, SpCO and SpMet functionality. With the current application, we are proposing to revise the X Series software to optionally support additional monitoring parameters - Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI) and Perfusion Index (PI), offered by the Masimo Rainbow SET Technology board that is installed in the currently marketed X Series device (K133269 and K133484).

The provided text describes ZOLL X Series device and its substantial equivalence to predicate devices, particularly concerning new monitoring parameters. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the ZOLL X Series (K142915) is an update to an existing device (K133269 and K133484) to include additional monitoring parameters: Total Hemoglobin (SpHB), Oxygen Content (SpOC), Pleth Variability Index (PVI), and Perfusion Index (PI). These parameters are enabled by the Masimo Rainbow SET Technology board, which was already installed in the device, through new software and licenses.

The key acceptance criterion is demonstrating substantial equivalence to the predicate device, the Masimo Radical 7 Pulse CO-Oximeter and Accessories (K110028), for these new monitoring parameters. The reported performance is that the ZOLL X Series, utilizing the same Masimo Rainbow SET Technology, has the same performance specifications as the predicate device for SpHB, SpOC, PVI, and PI.

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" for the new parameters in the context of a prospective clinical study directly for K142915. Instead, it relies on the performance of the Masimo Rainbow SET Technology, which was already established in the predicate device (K110028).

• Sample Size for Test Set: Not applicable/not explicitly stated for K142915. The evaluation for the new parameters leverages the performance data from the predicate device (Masimo K110028).
• Data Provenance: The performance of the Masimo Rainbow SET Technology board and its software for these parameters was "established and subsequently cleared by the agency under K110028." This implies the original data for K110028 would have included clinical or performance data for these specific parameters. The provenance of that original data (country, retrospective/prospective) is not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The substantial equivalence argument for the new monitoring parameters within K142915 hinges on the fact that the underlying technology and software for these parameters were already cleared under K110028 (Masimo Radical 7 Pulse CO-Oximeter). There is no mention of a new expert panel or ground truth establishment specifically for the K142915 submission regarding these parameters.

4. Adjudication method for the test set

Not applicable. As noted above, the submission relies on previously cleared technology and software.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical monitoring and defibrillation system, not an AI-assisted diagnostic imaging or interpretation tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance of the algorithm (Masimo Rainbow SET Technology software) for the additional parameters (SpHB, SpOC, PVI, PI) was established as part of the clearance for the predicate device, Masimo Radical 7 Pulse CO-Oximeter (K110028). The current submission states that the ZOLL X Series incorporates this same "relevant license and the software code" whose "performance of which was established under K110028." This implies a standalone evaluation of the algorithm's performance for these parameters occurred within K110028.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for the original Masimo K110028 clearance related to SpHB, SpOC, PVI, and PI. For physiological monitoring parameters like these, ground truth typically involves a reference standard measurement method (e.g., laboratory blood analysis for hemoglobin, or invasive continuous measurement for pressure/perfusion indices).

8. The sample size for the training set

The document does not provide information about a "training set" for the software in K142915. The evaluation relies on the already established performance of the Masimo Rainbow SET Technology from K110028. If machine learning was involved in the development of the Masimo algorithm, such information would have been part of the K110028 submission, but it's not referenced here for K142915.

9. How the ground truth for the training set was established

Not applicable, as no training set information is provided in this document for the K142915 submission.

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The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series, The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

The predicate X Series is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and respiration monitoring).

With the current application, we are proposing to revise the X Series communication processor software to create a web page with a graphical trend format and countdown timer for ventilations that consolidates the existing SBP (systolic blood pressure from the NIBP monitoring), SpO2, EtCO2 data and the timer on the display of the X Series. The access to this web page will be marketed as the Traumatic Brain Injury (TBI) Dashboard. This TBI Dashboard assists the operator who is ventilating a patient to follow recommendations in the TBI guidelines. Through an encrypted and password protected communications protocol, a suitable separate device with touchscreen, web browser capability and Bluetooth communications can display the TBI Dashboard.

As described above, the proposed software change impacts only the communication aspects of the X Series device. Therapeutic and monitoring capabilities of the X Series device as cleared under K133269 have remained unchanged and are not impacted by the proposed change. The X Series therapeutic and monitoring functionality is entirely controlled by access directly through the X Series device, itself, and not through the TBI Dashboard. TBI Dashboard is intended to supplement and not replace any part of the device monitoring.

The provided text describes the ZOLL X Series, a multi-function medical device that includes capabilities such as defibrillation, ECG monitoring, CPR monitoring, pacing, and various physiological monitoring functions (NIBP, temperature, SpO2, respiration, CO2, invasive pressure). The 510(k) submission (K141774) is specifically for a revision to the X Series communication processor software to add a "TBI Dashboard" functionality.

However, the document does not explicitly state specific acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy, error rates) for the device's various functions, nor does it provide detailed descriptions of studies proving these criteria are met. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.

The "Performance Testing" section states: "Extensive performance testing in the form of the software verification and system level validation ensures that the ZOLL X Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards." This is a general statement about the type of testing performed, not a detailed report of the results against specific criteria.

The 510(k) summary focuses on the TBI Dashboard functionality, which is a software revision. For this new feature, the document asserts substantial equivalence to two predicate devices:

• ZOLL RescueNet Link (K111296) for collecting and displaying data in a web page format.
• L770-CPR Resuscitation Timer (K062080) for ventilation rate timer functionality.

Given this, I will infer what the "acceptance criteria" likely are based on the substantial equivalence claims and the general nature of medical device clearances. The "reported device performance" will be based on the general statements made about meeting requirements.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not provide details on specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) for the software verification and system-level validation. The nature of the submission (a software update for a display feature) suggests that these tests would primarily involve engineering and software validation rather than clinical data from a "test set" in the traditional sense of patient data. For the original X Series functions, such data would have been part of the K133269 submission, but not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/provided. The submission relies on demonstrating substantial equivalence to predicate devices and general software verification/system validation, rather than a clinical study requiring expert-established ground truth for a novel diagnostic or treatment outcome.

4. Adjudication method for the test set

Not applicable/provided for the reasons stated above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or reported. This submission is for a device update adding a dashboard, not a novel diagnostic AI algorithm. The TBI Dashboard is described as a "supplement and not replace any part of the device monitoring," and the ventilation timer as a "visual aid," implying it supports human users rather than being an AI system that improves human "reading" performance in a diagnostic context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a patient monitor/defibrillator with software features, not a standalone algorithm. The TBI Dashboard is a display feature for existing data.

7. The type of ground truth used

For the software revision adding the TBI Dashboard, the "ground truth" would likely be the correct functioning of the software according to its design specifications, accuracy in displaying data from the device sensors, and adherence to accepted communication protocols for web page display. This would be established through software unit testing, integration testing, and system validation against known correct values or predicate device behavior. No external expert consensus, pathology, or outcomes data is mentioned for this particular update.

8. The sample size for the training set

Not applicable. The X Series and its TBI Dashboard are not described as machine learning or AI-based systems that require a "training set" for model development.

9. How the ground truth for the training set was established

Not applicable for the reasons stated above.

Ask a specific question about this device

The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the X Series in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

Semiautomatic Operation (AED): X Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the X Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

ECG Monitoring: The X Series is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.

External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia, Pediatric pacing.

Non-Invasive Blood Pressure Monitoring: The X Series is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg.

Temperature Monitoring: The X Series is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

SpO2 Monitoring: The X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.

Respiration Monitoring: The X Series is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor.

CO2 Monitoring: The X Series is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath rate.

Invasive Pressure Monitoring: The X Series is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

Web Console: X Series Web Console functionality allows medical personnel to view physiological data available on a connected X Series device. Physiological data may include ECG, noninvasive blood pressure, SpO2/SpCO/SpMet, end-tidal carbon dioxide, respiration rate, invasive blood pressure, temperature, and Heart Rate. For each patient connected to an X Series, the X Series collects patient data, consolidates the data on an embedded web page that can be requested, through an Ethernet connection, by a web browser on a PC for display.

The X Series (reviewed and cleared with K112432 on 03/21/2012) is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECC, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and impedance respiration monitoring). With the current application we are proposing to revise the X Series software to support Web Console functionality which will allow remote personnel to view the content of one or multiple (up to forty) X Series device screens. Users of the new Web Console features can only view the data on monitors remotely, and cannot operate the X Series device, silence device alarms, or initiate any patient treatment remotely - this can only be done directly on the device, at the patient's bedside.

The provided text is a 510(k) summary for the ZOLL X Series medical device, focusing on an update that adds "Web Console functionality." It does not contain information about acceptance criteria, device performance, or a study specifically proving the device meets acceptance criteria for its primary functions (defibrillation, monitoring, pacing, etc.). Instead, the document assesses the substantial equivalence of the new Web Console functionality to a predicate device.

However, I can extract information related to the demonstration of substantial equivalence for the new Web Console functionality.

Here's a breakdown based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific acceptance criteria or quantitative performance metrics for the Web Console functionality. It states that "Safety, efficacy and substantial equivalence was shown through software verification and system level validation." The basis for substantial equivalence is that the new functionality cannot control the connected devices, silence alarms, or initiate patient treatment remotely, which aligns it with the functions of the predicate device (ZOLL RescueNet Link K111296).

Study Information for Web Console Functionality:

The document describes the assessment for the new Web Console functionality rather than the entire X Series device's core functions.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified. The document refers to "software verification and system level validation" and "performance testing" but does not provide details on the number of cases or data points used in these tests for the Web Console functionality.
• Data Provenance: Not specified. The tests would likely involve simulated or real X Series device data, but the origin (e.g., country, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. The assessment for the Web Console functionality does not appear to involve establishing ground truth through expert review in the way a diagnostic AI might. The focus is on verifying its ability to display data and its inability to control the device remotely.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not specified. This type of adjudication method is typically used for clinical trials involving human interpretation of medical images or data, which is not the nature of the assessment described for the Web Console functionality.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC comparative effectiveness study was not done. The Web Console functionality is for viewing data, not for interpretation or diagnosis by AI affecting human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, in a sense. The "software verification and system level validation" and "performance testing" are evaluations of the algorithm/software functionality itself. However, it's not a standalone diagnostic algorithm that makes decisions. It's a viewer. The crucial "standalone" aspect here is that the Web Console cannot operate the X Series remotely, confirming its role as a viewer only.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not explicitly defined in terms of clinical ground truth. For the Web Console, the "truth" would be whether it accurately displays the data transmitted from the X Series device and whether it correctly prevents remote control actions. This is verified through "software verification and system level validation" against functional requirements and specifications.

8. The sample size for the training set:

• Not applicable. The Web Console is a software update for viewing data, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set for this functionality.

Ask a specific question about this device

The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the X Series in the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

Semiautomatic Operation (AED): X Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the X Series in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

ECG Monitoring: The X Series is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients.

External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia, Pediatric pacing.

Non-Invasive Blood Pressure Monitoring: The X Series is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user. Measurements are made using an inflatable cuff on the patient's arm or leg.

Temperature Monitoring: The X Series is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

SpO2 Monitoring: The X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet).

Respiration Monitoring: The X Series is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator.

CO2 Monitoring: The X Series is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate.

Invasive Pressure Monitoring: The X Series is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

The ZOLL X Series Defibrillator/Monitor cleared under 510k application K112432 is a light weight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitor (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and impedance respiration monitoring). X Series software has been revised to support the OneStep Pediatric CPR Electrode. This electrode was previously cleared for use with the ZOLL R Series (K120907). As in the R Series, the electrode will enable the X Series device to provide CPR monitoring for Pediatric patients. The labeling of the X Series will be revised to remove the contraindication "The CPR monitoring function is not intended for use on patients under 8 years of age" from the Indications For Use for CPR Monitoring currently cleared for the X Series (K112432).

The ZOLL X Series Defibrillator/Monitor (K133269) received 510(k) clearance based on its substantial equivalence to predicate devices (ZOLL X Series K112432 and ZOLL R Series K120907). The modification primarily involved a software revision to support the OneStep Pediatric CPR Electrode for pediatric CPR monitoring. The submission did not include a traditional study with acceptance criteria and reported device performance metrics in the typical sense of a diagnostic or predictive AI algorithm.

Instead, the acceptance criteria are implicitly tied to demonstrating that the modified device performs as well as the predicate devices and meets its functional and performance specifications, especially concerning the new pediatric CPR monitoring feature.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for a modification to an existing device, the "acceptance criteria" are not presented as specific performance metrics and thresholds (e.g., sensitivity, specificity) but rather as compliance with existing safety and performance standards, and comparison to predicate devices. The document explicitly states: "Extensive performance testing in the software verification and system level validation ensures that the ZOLL X Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards."

Therefore, a table of specific quantitative acceptance criteria and reported device performance values cannot be constructed from the provided text in the way one would for a diagnostic AI. The acceptance criteria essentially were:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data for a direct performance evaluation of the modified pediatric CPR monitoring algorithm. Instead, the assessment relies on software verification and system-level validation. This implies engineering tests rather than a cohort of patient data.

• Sample Size for Test Set: Not applicable/not specified as clinical test data in the provided document.
• Data Provenance: Not applicable, as no clinical test data for the specific modification is detailed. The assessment was based on engineering and validation testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The submission is based on engineering verification, system-level validation, and comparison to predicate devices. There is no mention of a test set requiring expert-established ground truth in the context of diagnostic performance for the new feature or the overall device.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was mentioned. The device provides CPR monitoring feedback; it is not described as an AI system assisting human readers in interpreting clinical data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device's CPR monitoring function provides automated feedback (rate and depth) but operates with a human rescuer in the loop. The document doesn't describe a "standalone algorithm" performance study in the absence of human interaction. The functions described are inherent to the device and its sensors, providing real-time data to the user.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the pediatric CPR monitoring feature, the "ground truth" would implicitly be the physical measurements of chest compression rate and depth, compared against the AHA/ERC recommended targets (e.g., 100 compressions per minute, 1.5-2.0 inches depth). This "truth" is established by physical measurement standards rather than expert clinical consensus or pathology. The document, however, does not detail the specific methodology for verifying the accuracy of these measurements. It states that "performance testing" and "software verification and system level validation" were performed.

8. The Sample Size for the Training Set

Not applicable. The document describes a software revision for a medical device. There is no mention of a "training set" for a machine learning or AI algorithm in the context of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for a machine learning or AI algorithm is mentioned.

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The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series. The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series unit can be used on pediatric patients, (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.

Manual Defibrillation: Use of the devicein the manual mode for external and internal defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. The unit can also be used for synchronized cardioversion of certain atrial or ventricular arrhythmias. Qualified medical personnel must decide when synchronized cardioversion is appropriate.

ECG Monitoring: The device is intended for use to monitor and/or record 3-, 5-, or 12-lead ECG waveform and heart rate, and to alarm when heart rate is above or below limits set by the operator.

External Transcutaneous Pacing: This product can be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia, Pediatric pacing.

Non-Invasive Blood Pressure Monitoring: The device is intended for use to make non-invasive measurements of arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the user.

Temperature Monitoring: The device is intended for use to make continuous temperature measurements of rectal, esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set by the user.

Respiration Monitoring: The device is intended for use to continuously monitor respiration rate and to alarm if the rate falls outside of the range set by the operator. Because the measurement method actually measures respiratory effort, apnea episodes with continued respiratory effort (such as obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor.

CO2 Monitoring: The device is intended for use to make continuous noninvasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate.

Invasive Pressure Monitoring: The device is intended for use to display and make continuous invasive pressure measurements from any compatible pressure transducer. The primary intended uses are arterial blood pressure, central venous pressure and intracranial pressure monitoring. Any contraindications of the particular transducer selected by the user shall apply.

Semiautomatic Operation (AED): The device is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse.

CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients.

SpO2 Monitoring: The X Series pulse CO-oximeter, with Masimo Rainbow SET technology and the Rainbow series of sensors, is intended for use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin saturation (SpMet). The pulse CO-oximeter and accessories are indicated for use on adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospital-type facilities, or in mobile environments.

12-Lead Analysis: The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data, and to provide interpretation of the data for consideration by caregivers. The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data.

The ZOLL Propaq MD device is being revised with additional features and optional modules. This configuration of the device will be marketed as the ZOLL X Series. The X Series is a light weight, portable device designed to be used by trained medical personnel who are familiar with basic monitoring, vital sign assessment and emergency cardiac care. As in its previous configuration, the X Series combines the functions of an ECG monitor, manual defibrillator, external transcutaneous pacer, pulse oximeter, noninvasive blood pressure monitor, invasive pressure monitor, respiration rate monitor and temperature monitor. Functions are offered as options and functions can be configured to meet the needs of a particular application. Additionally, the proposed configuration (ZOLL X Series) adds the following features: Semi-automatic external defibrillation function (AED) Mode, CPR rate and depth monitoring, See-Thru CPR ECG filtering, Inovise Audicor 12-Lead ECG Interpretive Algorithm, ECG Life Threatening Alarms, Masimo Rainbow MX3 Option with SpO2, SpCO, and SpMet monitoring, Oridion microMediCO2 module replaces miniMediCO2 module, Expanded Data Logging capabilities, Wide-format printer option, Wireless Data Transfer.

This document describes a 510(k) premarket notification for the ZOLL X Series, a multi-functional medical device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific, new acceptance criteria for the ZOLL X Series or detailing performance against them. Most performance claims are implicit in the statement of substantial equivalence to previously cleared devices.

However, the document mentions specific functional aspects and their intended performance:

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not provide specific details on the sample size used for the test set or the data provenance for the features mentioned (CPR monitoring, AED rhythm analysis, 12-lead ECG interpretation).

The filing relies heavily on the "substantial equivalence" argument, meaning that the performance of the integrated components (like the Inovise Audicor 12-Lead ECG Interpretive Algorithm) has already been established and reviewed in their original 510(k) clearances (e.g., K032145 for Inovise Audicor). The current filing does not present new clinical study data for these components themselves.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. For components like the 12-lead ECG interpretive algorithm, such details would have been part of its original 510(k) submission (K032145 for Inovise Audicor).

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A MRMC comparative effectiveness study is not explicitly mentioned or detailed in this 510(k) summary. The document emphasizes the device's functionality and substantial equivalence. For the 12-lead ECG analysis, it states, "The interpretations of ECG data offered by the device are only significant when used in conjunction with caregiver overread as well as consideration of all other relevant patient data." This implies a human-in-the-loop approach where the device provides information for the caregiver, but it does not quantify improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

For components like the AED's rhythm analysis function and the 12-lead ECG interpretive algorithm, standalone performance would have been evaluated as part of their original clearance processes. The current submission for the ZOLL X Series integrates these cleared algorithms. The 510(k) summary refers to "Specifications for the ECG rhythm analysis function are provided in the Operator's Manual section 'ECG Analysis Algorithm Accuracy' on page A-33," suggesting that standalone algorithm performance data exists but is not included in this summary.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not explicitly stated in the 510(k) summary. For the 12-lead ECG interpretive algorithm, it is highly likely that expert consensus (e.g., multiple cardiologists' interpretations) would have been used as ground truth in its original validation studies. For AED algorithms, ground truth for rhythm detection typically comes from expert review of ECG waveforms.

8. The Sample Size for the Training Set

The 510(k) summary does not provide any information regarding the sample size for the training set for any of the algorithms or features. This information would typically be part of the original development and validation of the individual algorithms (e.g., Inovise Audicor).

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the 510(k) summary. Similar to the test set ground truth, the methodology for establishing ground truth for training data would have been detailed in the original submissions for the individual algorithms.

Summary of the Study Discussed in the Document:

The provided document is a 510(k) summary (K112432) for the ZOLL X Series. It is not a detailed clinical study report but rather a regulatory filing designed to demonstrate substantial equivalence to previously cleared predicate devices.

The "study" presented here is a collection of performance and safety testing aimed at showing that the newly configured ZOLL X Series, incorporating additional features and modules, functions as intended and is as safe and effective as its predicates.

According to the document:

• Type of Study: The document describes "Extensive performance testing" and "Safety testing" to ensure the device performs as well as predicate devices and meets its specifications. It is a design verification and validation effort rather than a comparative clinical effectiveness trial.
• Purpose: To demonstrate that the ZOLL X Series' new features (e.g., AED mode, CPR monitoring, See-Thru CPR, Inovise Audicor 12-Lead ECG Interpretive Algorithm, Masimo Rainbow MX3, Oridion microMediCO2) are substantially equivalent to previously cleared devices or modules.
• Key Finding: The conclusion states, "The information provided in this 510(k) demonstrates that the ZOLL X Series' features and functions are substantially equivalent to those of the indicated commercially distributed devices with regard to performance, safety and effectiveness."

In essence, this 510(k) summary indicates that the ZOLL X Series meets its acceptance criteria by demonstrating that its integrated components and overall system performance are equivalent to those of devices already cleared by the FDA, relying heavily on the pre-existing validation of those predicate devices and modules.

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